Status:
UNKNOWN
Telerehabilitation Protocols With Digital and Robotic Tools for People With Chronic Neurological Disorders
Lead Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Collaborating Sponsors:
Fondazione Ico Falck
Conditions:
Post-stroke
Parkinson Disease
Eligibility:
All Genders
25-85 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to test an innovative telerehabilitation protocol in people with Chronic Neurological Disorders (Parkinson's disease, Multiple Sclerosis, and post-stroke). The main ...
Eligibility Criteria
Inclusion
- diagnosis of chronic post-stroke condition with ischemic or haemorrhagic stroke injury occurred 4-6months before recruitment and with motor impairment of the upper limb \> 2 to the Medical Research Council scale (MRC); or diagnosis of probable PD according to MDS criteria (Postuma et al., 2015) in staging between 1.5 and 3 on the Hoehn \& Yahr scale (Goetz et al., 2004); or diagnosis of MS, RR-SP forms, according to the criteria of MC Donald 2010 (Polman et al., 2011) with disability level at the Expanded Disability Status Scale EDSS (Kurtzke, 1983) \< 6;
- age between 25 and 85 years;
- preserved cognitive level at the Montreal Cognitive Assessment test (MoCA test \>17.36) (Conti et al., 2015);
- agreement to participate with the signature of the informed consent form;
- no rehabilitation program in place at the time of enrolment;
- stable drug treatment (last 3 months) with L-Dopa or dopamine agonists (PD group) and/or cortisone (MS group).
Exclusion
- presence of comorbidities that might prevent patients from undertaking a safe home program or determining clinical instability (i.e., severe orthopedic or severe cognitive deficits);
- presence of major psychiatric complications or personality disorders;
- presence of severe impairment of visual and/or acoustic perception;
- relapse ongoing/at least 3 months since the last relapse (MS group);
- presence of "frequent" freezing as recorded at the administration of Section II (daily life activity) of the UPDRS (score ≥ 3) (PD group);
- falls resulting in injuries or a number of falls ≤ 2 in the 6 months prior to recruitment (PD and MS groups).
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06009770
Start Date
September 1 2023
End Date
January 1 2025
Last Update
August 24 2023
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